A number of operating room table accessory devices have been developed in an attempt to restrain patients from sliding downwards on the table when the table is tipped into a head down angulation. This position is known in the industry as the Trendelenburg position. The Trendelenburg position is often utilized when internal visualization of and access to the pelvis is required for robotic assisted laparoscopic surgery, minimally invasive surgery and traditional open surgery. When the Trendelenburg position is achieved, gravity causes the internal organs to shift toward the head thereby improving visualization and surgeon access to the pelvic anatomy. The medical literature shows that if the patient is not restrained when they are placed into the Trendelenburg position, then there is a real risk that the patient will slide off the table suffering severe or life ending injury.
Several devices are described in the medical literature as being effective in anchoring the patient in position to keep them from sliding on the table. The medical literature shows clearly that using fixed shoulder braces to restrain patients from sliding is effective. However, the medical literature also makes clear that these devices commonly cause serious nerve damage and strongly cautions against the use of shoulder braces. For example, it is known that with the use of shoulder braces, the combination of gravity and the patient's weight forces or “funnels” the patient's mass between the braces. This distorts the clavicle, which places direct pressure on the brachial plexus, which is to be avoided. It is further known that extra padding on shoulder braces does not reduce patient risk, stop funneling or reduce the cause of brachial plexus injury. A number of other contemporary alternatives, such as restraining the patient directly to the surgical table using tape and foam, may keep the patient from sliding off the table with little risk of nerve injury. Even so, it is not uncommon that during the course of traditional laparoscopic and open surgical procedures for the devices and/or the patients to slide anywhere from 1 to 8 inches during the course of a surgical procedure. The sliding occurs quite slowly and gradually, and commonly becomes obvious only at the end of the procedure after removal of protective surgical drapes. It most often presents as a noticeable reduction of leg flexion when utilizing booted stirrups. When performing conventional minimally invasive surgical procedures the concern for patient risk due to sliding a few inches when in Trendelenburg appears to have been relatively low. This, however, is not so for robotic procedures.
With the advent of robotic assisted laparoscopic surgery, many procedures are done in the most extreme Trendelenburg postures available from the surgical table. The angle of head down tilt typically ranges from 30° to 45° with respect to a ground surface. Patients' sliding on the table during robotic surgery is becoming recognized globally as a serious patient positioning risk. Sliding during robotic surgery places the patient at serious risk for injury at the site where the surgical instruments and visualization equipment enter the patient. The effects of patients sliding while in the Trendelenburg position during robotic surgery cannot be ignored because the robot is not programmed to detect if a patient is moving or sliding on the table. When a patient slides, even just one half of an inch, the robot is not programmed to adjust either the mechanical arms or instruments to the change in the patient's position on the table. Therefore, when a patient slides during robotic assisted surgical procedures, the robotic arms and instruments remain in their fixed location as programmed. This can result in the added sliding weight of the patient being shifted from the restraint device to the robotic arms and the attached instruments. Ultimately, the patient may be restrained by the instruments entering the body and trocars. This has been ironically referred to as “the meat hook” restraint technique. Analysis of the medical literature suggests that patient injuries from sliding on the table during robotic procedures will present as incisional tear, post-operative hernia formation, and increased postoperative pain secondary to overstretching of the anterior abdominal wall causing severe and prolonged post-operative pain, bruising or even necrosis at the primary sites of instrument and camera entry.
Some examples of this type of bracing and restraining devices are disclosed in U.S. Pat. No. 5,090,073 to Nordan et al. and U.S. Pat. No. 6,622,324 to Van Steenburg et. al., the latter being an advanced representation of the current state of the art. The instant invention provides an innovative device that eliminates or minimizes intraprocedural patient sliding, meets or exceeds the clinical needs for safety, provides acceptable anesthesia access and surgical site exposure, and offers an intuitive design that is easy and fast to use.